Paracetamol product-specific bioequivalence guidance
This document provides product-specific guidance on the demonstration of the bioequivalence of paracetamol.
Keywords: Bioequivalence, generics, paracetamol
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- Cmax: maximum plasma concentration
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Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - First version (PDF/78.2 KB)
Adopted
First published: 01/02/2018
Last updated: 01/02/2018
Legal effective date: 01/08/2018
EMA/CHMP/356877/2017 -
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Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2017) - First version (PDF/92.74 KB)
First published: 01/02/2018
Last updated: 01/02/2018
EMA/CHMP/729976/2017 -
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Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version (PDF/78.48 KB)
Draft: consultation closed
First published: 28/07/2017
Last updated: 28/07/2017
Consultation dates: 28/07/2017 to 31/10/2017
EMA/CHMP/356877/2017
